| NALOXONE HYDROCHLORIDE |
208872 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/03/14
|
2017/03/14
|
RISING |
Prescription |
| NALOXONE HYDROCHLORIDE |
207634 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/07/26
|
2017/07/26
|
SOMERSET THERAPS LLC |
Prescription |
| NALOXONE HYDROCHLORIDE |
207633 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2017/08/08
|
2017/08/08
|
SOMERSET THERAPS LLC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
204383 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2017/10/24
(TA)
|
--
|
ACTAVIS LABS UT INC |
None (Tentative Approval) |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207000 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2017/12/13
|
2017/12/13
|
SPECGX LLC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207000 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2017/12/13
|
2017/12/13
|
SPECGX LLC |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205299 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205299 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205806 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 4MG BASE;EQ 1MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205806 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
DR REDDYS LABS SA |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
207607 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2018/06/14
|
2018/06/14
|
MYLAN TECHNOLOGIES |
Prescription |
| NALOXONE HYDROCHLORIDE |
207846 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
No
|
No
|
2018/12/17
|
2018/12/17
|
CHARTWELL RX |
Discontinued |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
001 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 2MG BASE;EQ 0.5MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
002 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 4MG BASE;EQ 1MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
003 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 8MG BASE;EQ 2MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
205954 |
004 |
ANDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FILM;BUCCAL, SUBLINGUAL |
EQ 12MG BASE;EQ 3MG BASE |
No
|
No
|
2019/01/24
|
2019/01/24
|
ALVOGEN |
Prescription |
| NALOXONE HYDROCHLORIDE |
209522 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
4MG/SPRAY |
No
|
No
|
2019/04/19
|
2019/04/19
|
TEVA PHARMS USA |
Over-the-counter |